Do you need a basic introduction to aspects of validation or would you like an overview covering 500 pages of validation? We will be happy to help you through your first steps in BAYOOSOFT Risk Manager validation as part of a full-day training course. Following an introduction to the basics, you and one of our trainers will look at the existing documents and start directly with the first aspects of validation.
Do you want to accelerate your approval process, but unsure how?
Software Validation – Your Service Options
All systems involved in the process need to be validated in accordance with DIN EN ISO 13485:2017. BAYOOSOFT Risk Manager has a validation process based on the GAMP 5 guidelines for computerized validation according to these requirements and is validated as category-four software.
Frequently Asked Questions
Is BAYOOSOFT Risk Manager validated?
BAYOOSOFT Risk Manager is validated according to ISO 13485. Based on the GAMP 5 guidelines for computerized validation, the market-leading software solution was validated as category-four software and successfully passed all aspects – from the requirements and configuration specifications through to the acceptance test. To simplify the validation process, we offer a pre-validation package with all necessary documents
Can reports generated in BAYOOSOFT Risk Manager be submitted to the FDA?
The reports generated in BAYOOSOFT Risk Manager can be submitted to designated bodies in Europe as well as the FDA in accordance with FDA 21 CFR Part 11. The software solution meets the requirements of the guideline through the specific system settings in the application, with the three criteria “Apply Password Rules”, “Use Audit Trail” and “Use Digital Signature”.
What is the knowledge database and what advantages does it offer?
The integrated knowledge database allows synergies to be used and reduces loss of knowledge associated with staff turnover. Continuously developing a knowledge platform allows efficient, cross-project work. When creating new elements, BAYOOSOFT Risk Manager recognizes whether they already exist in the same or other projects or in the knowledge database and automatically suggests them. This prevents redundant data and enables cross-project knowledge transfer. CSV imports are also available.
Working with the knowledge database takes place in template management and the user must be assigned the right “Define Templates” or role “Template Manager” to this end.
Suggestion lists can support you by providing frequently recurring elements for preparing a new risk analysis. They help contribute to utilizing company knowledge as efficiently as possible. Groups are used as suggestion lists for new elements in the analysis program section.
Groups are managed depending on the device type. For this reason, you first always need to select the desired device type in the corresponding list fields.
Does the system include content-based rights management?
BAYOOSOFT Risk Manager includes fine-grained user and role management, which meets the requirements of MDR 2017/745 and implements content-based rights management. Depending on the role, users can be assigned certain rights. As a team member of individual project versions, the rights of this global configuration are adopted, but can still be individually adjusted in each project version. The standard roles are as follows:
- Measure Manager
- Project Lead
- Template Manager
- Requirements Engineer
- Clinical Evaluation Manager
Roles and rights are managed in the administration area / user management or role management and can be further specified for individual projects if needed.
What does “inherit rights” mean in a project?
If you have placed a checkmark for “inherit rights”, the rights indicated in the administration area under user management will be assigned automatically. To issue rights to a user that deviate from those entered in the administration area, remove the checkmark on the project team page and click on the user. The rights available will then be displayed and can be adjusted accordingly for the opened project.
After installing the software, I am asked for my user name and password. How can I register in the system?
The risk analyses prepared using BAYOOSOFT Risk Manager can contain sensitive company data. For this reason, access to the system is protected by user registration. In order to test the software, the following demo users are provided with the installation:
Demo user – project management:
User name: sieber
Demo user – administration:
User name: admin
What import and export options does the system offer?
All project versions of BAYOOSOFT Risk Manager can be exported and imported for conversion into QRM4e format. In addition, numerous import functions via CSV or Excel are available – such as requirements templates.
How do I activate our full license?
If you have purchased a full license of BAYOOSOFT Risk Manager, you can either carry out a new installation or update your existing test version. In the case of a new installation, the registration form appears directly after opening the system. For test versions, you can do so by clicking on the BAYOOSOFT Risk Manager logo in the top left and then “Register”.
You can enter your license key in the “Full Version” area in the registration form. Then click on “Activate full version”. Following activation, you can find the license information for your company under “License Details”.